We are seeking an experienced cross functional Project Manager to be part of our PMO. This is a key position in bringing to market a miniature robotic system to change the world of robotic assisted surgery.
The candidate will be responsible for managing key strategic projects - from project Initiation to launch, including project planning, risk assessment, resource management, and timely communication of key milestones and deliverables. The projects may range from product development for commercial launches, for clinical studies or advanced technology feasibility initiatives.
The candidate should have had multiple cycles of success running complex projects through a complete product life cycle in the medical device industry. He/She should be able to work successfully in a fast-paced environment including multiple platforms, architectures and global teams. The individual will work closely with R&D, engineering, marketing, product managers, clinical, regulatory, quality, supply chain and other cross functional members as required.
Roles and Responsibilities
Define project needs and lead the project through its product development cycle from project charter to launch.
Develop detailed project plan that is both holistic and detailed and takes into account both design control deliverables and other deliverables required for a clinical study or commercial launch.
Proactively manage changes to the project scope, schedule and costs.
Coordinate internal and third parties/vendors resources for the project different tasks.
Ensure resource availability and allocation.
Be adept at working with external partners located globally and integrating them into the team.
Responsibility for the design control process of the project and deliverables associated with project phase/stage gates.
Responsibility for communicating project status within project team and management.
Work in conjunction with the Engineering team to support manufacturing scale-up, incorporate new design changes, and make manufacturing improvements.
2-4 years of experience managing projects in the medical device industry that includes multi-disciplinary systems.
Deep expertise of product development best practice and process, having both big picture awareness and hands-on knowledge.
Project management for class II medical devices is a plus
Strong communications skills in both English and Hebrew.
Deep technological understanding and creativity in hands-on problem solving
Strong writing capabilities in Hebrew and English
Self-starter, self-learner, and self-organizer
Indications for use: The Hominis® Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms® during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis® Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Hominis® Surgical System are indicated for the following benign procedures: Total Benign Hysterectomy with Salpingo-Oophorectomy • Total Benign Hysterectomy with Salpingectomy • Total Benign Hysterectomy • Salpingectomy • Oophorectomy • Adnexectomy • Ovarian cyst removal. Caution: The safety and effectiveness of the Hominis® Surgical System was established only for the representative uses mentioned in the Indications for Use. The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying is ease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon. The prescription-use symbol or “Caution: Federal law restricts this device to sale by or on the order of a physician.” For safety information, including risks, indications, and specific warnings and cautions related to the Hominis System please refer to the Hominis Surgical System Instructions for Use provided with your Hominis Surgical System.